FDA.reportPublic FDA data

Cytotec

Product NDC
0025-1461
11-digit product format
000251461
Labeler code
0025
Product ID
0025-1461_253d5240-18d7-4f06-8314-a5632648cd47
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
misoprostol
Dosage form
TABLET
Route
ORAL
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
NDA019268
Marketing category
NDA
Marketing start
1986-12-27
Substance
MISOPROSTOL
Active strength
200 ug/1
Pharmacologic classes
Prostaglandin E1 Analog [EPC], Prostaglandins E, Synthetic [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cytotec
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MISOPROSTOL200 ug/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
73109aa8-3e7c-b7a0-fb29-6f84db91e7d9Product name320231221
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0025-1461-31Cytotec100 in 1 BOTTLE, UNIT-DOSETABLET10021
0025-1461-34Cytotec100 in 1 CARTONTABLET10021
0025-1461-34Cytotec1 in 1 BLISTER PACKTABLET121
0025-1461-60Cytotec60 in 1 BOTTLE, UNIT-DOSETABLET6021

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0025-1461-31EA - Each0025-146186bf4365-ecf7-4493-90ba-cbead63d0a4612012-07-24
0025-1461-34EA - Each0025-14613b22c2e0-862d-4389-9103-27bf170f85c612012-07-24
0025-1461-60EA - Each0025-1461c9fb7536-5c95-4eda-ab4b-cbc02aae7e3212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYDROGENATED CASTOR OILINACTIVE INGREDIENTZF94AP8MEYCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOCYTOTEC (MISOPROSTOL) TABLET [G.D. SEARLE LLC DIVISION OF PFIZER INC]7
MISOPROSTOLACTIVE INGREDIENT0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]1
MISOPROSTOLACTIVE MOIETY0E43V0BB57CYTOTEC (MISOPROSTOL) TABLET [APOTHECA, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0025-1461CYTOTEC (MISOPROSTOL) TABLET [PFIZER LABORATORIES DIV PFIZER INC]19Current NDC, Legacy NDC, 4 package rows20250221_4ab12da7-5731-4e06-bf1c-bc3f2e711f12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
209177Cytotec 100 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cytotec 200 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727miSOPROStol 100 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128miSOPROStol 200 MCG Oral TabletPSN4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177misoprostol 0.1 MG Oral Tablet [Cytotec]SBD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098misoprostol 0.2 MG Oral Tablet [Cytotec]SBD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727misoprostol 0.1 MG Oral TabletSCD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128misoprostol 0.2 MG Oral TabletSCD4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cyotec 200 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177Cytotec 0.1 MG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cytotec 0.2 MG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
209177Cytotec 100 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
311727misoprostol 100 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
317128misoprostol 200 MCG Oral TabletSY4ab12da7-5731-4e06-bf1c-bc3f2e711f1221
104098Cytotec 200 MCG Oral TabletPSN10644068-fa47-4e3b-9e93-f57ebac3dd171
317128miSOPROStol 200 MCG Oral TabletPSN10644068-fa47-4e3b-9e93-f57ebac3dd171
104098misoprostol 0.2 MG Oral Tablet [Cytotec]SBD10644068-fa47-4e3b-9e93-f57ebac3dd171
317128misoprostol 0.2 MG Oral TabletSCD10644068-fa47-4e3b-9e93-f57ebac3dd171
104098Cyotec 200 MCG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171
104098Cytotec 0.2 MG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171
317128misoprostol 200 MCG Oral TabletSY10644068-fa47-4e3b-9e93-f57ebac3dd171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0025-1461-3100025146131100 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-31) 100 tablet1986-12-270000-00-00NoNoCurrent
0025-1461-3400025146134100 in 1 CARTONHistorical
0025-1461-600002514616060 TABLET in 1 BOTTLE, UNIT-DOSE (0025-1461-60) 60 tablet1986-12-270000-00-00NoNoCurrent